Curia Global offers a variety of aseptic contract manufacturing services to help you get your medicine to clinical trial.
GMP Manufacturing Capabilities and Capacity
Our filling capabilities include vials, syringes, and cartridges for both liquid and lyophilized formulations with a high accuracy for both aqueous and viscous solutions. Automated filling capabilities allows us to offer a wide range of batch configurations and sizes.
- 1 – 100 L batch volumes depending on product characteristics and filling volumes
- Max liquid batch size: 20,000 vials (CAM) and 7,500 (GLA)
- High potency formulations
- Controlled substances
Our fill/finish suites have independent HVAC systems that allow us to handle cytotoxic and noncytotoxic materials. Our manufacturing philosophy is based upon the use of single use, fully disposable fluid pathways.
All our manufacturing spaces are within traditional EU classification:
- Aseptic filling – Grade A closed RABS cabinet within Grade B background
- Bulk formulation – Grade C
- Washing/Loading of Autoclave – Grade C
We offer a wide array of drug container closure systems for your liquid/lyophilized drug product including:
- Syringes (1 mL – 2.25mL)
- Cartridges (1.5 – 3 mL)
- Vials (2mL – 20 mL) or GLA (2 mL – 50 mL)
Current Good Manufacturing Practices (“cGMPs”) – Applicable regulatory requirements with respect to a country or regulatory jurisdiction in the USA and UK as amended from time to time, for the then-current standards under Applicable Law for the Manufacturing, preparation, processing, labeling, packaging, and distribution of pharmaceutical and/or biological products (and components thereof), including as set forth in (a) 21 U.S.C. Section 501(a),21 C.F.R. § 11, 210, 211, EU GMP Volume 4, and the guidance documents issued by the FDA and MHRA.
The company has carried and maintained a Drug Manufacturing License from the State of California Department of Public Health Food and Drug Branch since 2012.
The company is registered on the FDA Drug establishment site. The FDA Facility Establishment Identifier Number (FEIN) is: 3006188248.
The company holds an Investigational Medicinal Products Authorization licensed by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). MIA (IMP) Number 19124.
Lyophilized product batch sizes can range from 150 to 7,500 vials depending on your required presentation. We can conduct Engineering Runs to monitor assure a smooth transfer or development of your product specific cycles.
- To increase efficiency, precision, and control of the lyophilization process, we incorporate NIST traceable calibration programs, and robust maintenance programs for all equipment and utilities.
- We also provide lyophilization cycle development services with over 30 years of collective cycle development experience.
Our in-house microbiology & quality control laboratories provide:
- All environmental monitoring programs required of GMP clean rooms and process utilities.
- Analytical testing in support of process development activities
- Finished product testing
- Stability program management and testing.
GMP QCL Testing Services:
|Endotoxin||HPLC (RP,SEC, IEX, etc.)|
|pH & Conductivity||UPLC|
|Capillary Electrophoresis||Sub-visible particle analysis (HIAC & DLS)|
|Osmolality||Plate Assay (BCA, Activity, etc.)|
|Moisture Analysis||Total Organic Carbon|
|Container Closure Integrity Tests||Uniformity of Dosage|
These customized programs are designed for compliance with ICH/GMP guidelines.
- State-of-the-art validated chambers
- Full range of stability recommended and accelerated storage conditions
- 24-hour monitored facilities with overlapping back-up systems
- Dedicated responsive staff to address alarms and temperature excursions
In-house ICH stability programs available:
- 2 – 8 °C
- 25°C/60% RH
- 30°C/65% RH
- 40°C/75% RH
- Document Control
- Batch Records
- Change Control
- Batch Disposition
Laboratory Control System
- Laboratory Procedures
- Analytical Methods
- Sample Management
- Facility Cleaning
- Equipment Cleaning
- Environmental Monitoring
- Water Systems
- Work Order Program
- Facility Monitoring/AEMS
Packaging/Labeling and Raw Material Control
- Label Control
- Label Inspection and Packaging
- Raw Material Program
- Lot Numbering
- Internal Audits
- Management Review
- Risk Management
- Complaint Handling
- Product Recall
- Supplier Qualification